Special Notices. Each Party shall notify the other by telephone as soon as practicable (with written confirmation within three business days) upon its receipt of any technical complaint or notice of severe adverse reaction (hypoglycemia shall not be considered an SAE); provided, however, that notification of serious, new or unexpected experiences reported with increased frequency shall be made immediately (but in any event not more than thirty-six (36) hours after the notifying Party learns of such experiences). All such notices shall be directed to the Parties at the addresses set forth in Section 19.1 to the attention of the following personnel: If to DANCE: Technical complaints: Quality Assurance Specialist/ Staff Adverse reactions: Director of Product Surveillance/ Compliance Officer If to JULPHAR: Technical complaints: Site Quality Manager Adverse reactions: Site Quality Manager
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Samples: Supply Agreement, Supply Agreement (Dance Biopharm, Inc.)
Special Notices. Each Party shall notify the other by telephone as soon as practicable (with written confirmation within three business days) upon its receipt of any technical complaint or notice of severe adverse reaction (hypoglycemia shall not be considered an SAE); provided, however, that notification of serious, new or unexpected experiences reported with increased frequency shall be made immediately (but in any event not more than thirty-six (36) hours after the notifying Party learns of such experiences). All such notices shall be directed to the Parties at the addresses set forth in Section 19.1 to Section19.1to the attention of the following personnel: If to DANCE: Technical complaints: Quality Assurance Specialist/ Staff Adverse reactions: Director of Product Surveillance/ Compliance Officer If to JULPHARDONGBAO: Technical complaints: Site Quality Manager Adverse reactions: Site Quality Manager
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Special Notices. Each Party shall notify the other by telephone as soon as practicable (with written confirmation within three business days) upon its receipt of any technical complaint or notice of severe adverse reaction (hypoglycemia shall not be considered an SAE)reaction; provided, however, that notification of serious, new or unexpected experiences reported with increased frequency shall be made immediately (but in any event not more than thirty-six (36) hours after the notifying Party learns of such experiences). All such notices shall be directed to the Parties at the addresses set forth in Section 19.1 20.1 to the attention of the following personnel: If to DANCE: Technical complaints: Quality Assurance Specialist/ Staff Specialist Adverse reactions: Director of Product Surveillance/ Compliance Officer Surveillance If to JULPHARSAD: Technical complaints: Site Quality Manager Adverse reactions: Site Quality Manager
Appears in 1 contract
Samples: Manufacturing Agreement (Oramed Pharmaceuticals Inc.)
Special Notices. Each Party shall notify the other by telephone as soon as practicable (with written confirmation within three business days) upon its receipt of any technical complaint or notice of severe adverse reaction (hypoglycemia shall not be considered an SAE); provided, however, that notification of serious, new or unexpected experiences reported with increased frequency shall be made immediately (but in any event not more than thirty-six (36) hours after the notifying Party learns of such experiences). All such notices shall be directed to the Parties at the addresses set forth in Section 19.1 to the attention of the following personnel: If to DANCE: Technical complaints: Quality Assurance Specialist/ Staff Adverse reactions: Director of Product Surveillance/ Quality Assurance/ Compliance Officer Staff. If to JULPHARAERO PUMP: Technical complaints: Site Quality Manager Adverse reactions: Site Quality Manager
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Special Notices. Each Party shall notify the other by telephone as soon as practicable (with written confirmation within three business days(3) Business Days) upon its receipt of any technical complaint or notice of severe adverse reaction (hypoglycemia shall not be considered an SAE)reaction; provided, however, that notification of serious, new or unexpected experiences reported with increased frequency shall be made immediately (but in any event not more than thirty-six (36) hours after the notifying Party learns of such experiences). All such notices shall be directed to the Parties at the addresses set forth in Section 19.1 4.1 to the attention of the following personnel: If to DANCEAventis: Technical complaints: Quality Assurance Specialist/ Staff Specialist Adverse reactions: Director of Product Surveillance/ Compliance Officer Products Surveillance If to JULPHARInyx: Technical complaints: Quality Assurance Specialist – Manatí Site Quality Manager Adverse reactions: Site Quality ManagerV.P. Regulatory Compliance
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Samples: Manufacturing Agreement (Inyx Inc)